US FDA: No Timeframe On Combo Products Council Response To Industry Feedback
Industry stakeholders are still confused about the scope of the recently formed Combination Products Policy Council. In the meantime, the council says it doesn't have a specific timeframe by which it will address the issues industry has identified as priority topics.
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A top FDA device official says the agency is hoping to finalize an additive manufacturing guidance this year. Industry is particularly interested in seeing the leap-frog guidance made final, but would also like to see more clarification and a separate guidance to address the topic of patient-specific manufacturing.
A range of topics were raised in feedback provided by industry groups to FDA about what the priorities should be for the agency's new Combination Products Policy Council, but addressing inter-center disagreements was a repeat concern. Also raised: misaligned communication policies; pediatric combo-product reviews; and implementation of the 21st Century Cures Act.
To enhance combination product reviews, drug-fee revenue will pay for related positions in the agency's Center for Devices and Radiological Health.